Study finds significant PrEP use in gay men throughout Europe; France starts its programme

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European demonstration projects and opinions on PrEP

A meeting a month ago at the European Centre for Disease
Control (ECDC) in Stockholm found that cost was regarded as the biggest barrier
to the adoption of HIV pre-exposure prophylaxis (PrEP) by European countries. Many regarded
significant price reductions in the drugs used as a pre-condition for adopting
PrEP.

The ECDC held the meeting to discuss considerations for PrEP
implementation throughout Europe and invited clinicians, researchers, epidemiologists,
community advocates and, significantly, a high proportion of representatives
from various countries’ Ministries of Health – the people who would actually
make recommendations on PrEP to their governments.

The ECDC conducted a survey of 31 European countries as part
of the monitoring work it does on the implementation of the 2004 Dublin
Declaration on fighting HIV in Europe and Central Asia. It found that 17
countries ranging from Portugal to Azerbaijan had demonstration projects of
PrEP either in progress or planned.

It also asked: “What issues are limiting or preventing the
implementation of PrEP in your country?” By far the most common issue cited was
cost. Twenty-one out of the 31 countries considered the cost of PrEP drugs as a
highly important limiting factor and only two considered it of low importance;
the second most important limiting factor was the cost of service delivery,
which 11 countries considered as highly important and again only two of low
importance.

Compared with these, the medical or moral objections often
used against PrEP were less often cited. While lower condom use as a possible
consequence of PrEP was cited by 20 countries as of some importance only five
thought it was of high importance and increases in sexually transmitted infections (STIs) were cited by seven
countries as a possibly highly-important consequence.

Other cost issues that the ECDC meeting highlighted as
important included the fact that only in the UK and the Netherlands have thorough
cost-effectiveness studies of PrEP been done and that even if models do show
PrEP to be cost-effective, PrEP programmes will require a considerable initial
spend before they start achieving significant-enough reductions in infections.
There was general consensus that the barriers to rolling out PrEP would be
considerably lower once drugs come off-patent and are available at generic
prices.

The meeting looked at a number of other issues that might
need to be addressed in order to make accessing PrEP easier in Europe.

One particularly important consideration is the sheer
difference in healthcare systems from one country to another. This makes a
standard European ‘template’ for adopting PrEP impossible, and requires each
country to come up with its own answers.

Who, for instance, will provide PrEP? STI clinics? Community
testing sites? Infectious disease physicians? Primary care physicians? Through
online order schemes? Different arrangements and even laws already exist in
different countries on who can conduct an HIV test and these are likely to
affect PrEP provision too.

Hornet study: 10% of respondents ‘are taking PrEP’

As part of the preparation for the meeting, the ECDC also
collaborated with the gay social network site Hornet
on a rapid survey about PrEP. Despite the survey only being online for three
days (23-25 April), 8543 men answered the survey. A quarter of these were from
France, 22% from the UK, and, interestingly, 10% were from Russia, where Hornet
is the most widely used gay social app.

Eleven per cent of respondents were HIV-positive and 10% did
not know their status, leaving 79% (7519) of respondents who were HIV negative. Of
them, an extraordinarily high proportion – one in ten – said they were taking
PrEP, and 69% said their health provider was aware of this fact.

People were asked where they got PrEP. Only 528 men actually
answered this question. Excluding France, where PrEP is available through the
healthcare system, 47% of respondents said they sourced PrEP through the
internet; 24% through their physician; 15% from a friend; and 14% because they
were in a study. A tiny proportion (1%) were sourcing PrEP through making
repeat requests for post-exposure prophylaxis (PEP).

Thirty-one per cent said they were ‘very likely’ to use PrEP
at some point in the next six months, though an equal proportion said they very
unlikely to.

In France, 63% of respondents said they were acquiring PrEP
through their doctor and 22% through a research study (presumably Ipergay). Only 8% were buying it online and
6% getting it from friends – a completely different pattern, and the first
evidence showing the difference in acquisition being made by providing it
through the healthcare system.

First data on PrEP programme in France

In the case of France, Ipergay’s principal investigator,
Jean-Michel Molina, provided the first data on the PrEP programme in France
since it started in January. This is based on a measure available in French law
called a Temporary Recommendation for Use (RTU), which was issued in
November and lasts for three years, though it is renewable.

Sixty clinics are now offering PrEP, starting with clinics
in the Ipergay sites in Paris, Lyon, Nice, Lille and Nantes. In the first three
months of the programme’s operation, 437 people had started PrEP through the
healthcare system. This might be something like 2% of the people in France who
need it, as it is estimated that between 10,000 and 20,000 people in France are
in the high-risk categories who would benefit from PrEP.

PrEP is on offer to gay men and trans men or women who have
had anal sex without a condom with at least two partners in the last six
months, or had an acute STI in the last year, or who had more than one course
of PEP, or who reported frequent use of drugs during sex. PrEP for other groups
was considered on a case-by-case basis but could include people with acute
STIs, who had had condomless sex with someone from a high prevalence area or
who injected drugs, or female sex workers who reported condomless sex.

Contrary to previous reports, PrEP is not solely being offered on an intermittent or on-demand basis;
people are offered daily PrEP with an option to take it intermittently, as per
the Ipergay protocol.

The way the French healthcare system works means that PrEP is not entirely
free. The €500 monthly cost of the drug is borne by the healthcare system, but
people pay their doctor €23 upfront, 70% of which is reimbursable; baseline
tests for HIV, hepatitis B and C, STIs, creatinine and liver enzymes cost €190,
of which a minimum of 60% is reimbursable; and the one-month and quarterly
monitoring tests cost €23 of which all but €2 is reimbursible.

This means that the upfront cost post-reimbursement of
starting PrEP could be €91, though patients with additional insurance or on
social security would pay a lot less.

Data on patient characteristics, whether daily or intermittent
PrEP is being prescribed, adverse events and HIV infections are reported to a
website at https://www.rtutruvada.fr
which Truvada manufacturers Gilead
were required to set up as part of the RTU agreement.

Molina presented an analysis of the first 249 PrEP users at the Paris St
Louis clinic, up to mid-April 2016, which represented 40% of PrEP users in the RTU up to that point. All but one were gay men, 86%
were French nationals, most were employed and had completed secondary education
and 72% were single. Over a third (37%) had been told about PrEP by a friend,
26% by looking it up online, and 19% by the main French HIV NGO, AIDES.

About 75% chose intermittent PrEP and 25% daily, though Molina commented that these proportions may change as other clinics get more involved.

One in six had used PrEP before going to the clinic and over
half had a history of using PEP. A third had had sex with a partner they knew
to have HIV. Two PrEP-seekers at screening turned out to have HIV (0.8%). The
average number of sexual partners they had had in the previous three months was
18 and the number of occasions of condomless anal sex in the last four weeks
was five. Forty-four per cent had used psychoactive drugs (ecstasy, crack cocaine,
methamphetamine, amphetamine, GHB/GBL) in the last four weeks. One in five
users were referred to psychiatric follow-up for mental health support.

Eighty-six per cent started PrEP at their first visit.
There were two HIV infections detected in the 249 patients; neither had
actually started taking PrEP.

Jean-Michel Molina said that remaining scepticism about PrEP
in physicians, the gay community, funders and the general population needed to
be addressed, and that there needed to be more awareness of PrEP among doctors
and people at risk (MSM, transgender, and, especially, heterosexual migrants).

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap

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checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member
of your healthcare team for advice tailored to your situation.